2011 - maintenantProject teams manager for the development and transfer to industrial site of Company's first injectable pharmaceutical drug products, until regulatory file submission.
• Lead of analytics, manufacturing, engineering, R&D, RA, QA teams members.
• French and US teams.
• Strategy, planning, and budget management within overall development program.
• Part of implementation of project management activity and tools.
Becton & Dickinson
- Technology Transfer Supervisor
2009 - 2013Project Teams manager and member for the industrial transfer and scale-up of Company's first injectable pharmaceutical drug products .
• Creation of the Tech Transfer activity with US production site teams.
• Execution of Company's first injectable pharmaceutical drug products process transfers.
• Support to R&D department activities.
• Hierarchical management and transversal (project) management of engineers and technicians. French and US teams.
2007 - 2009RA team member for injectable pharmaceutical drug products development and registration.
• Creation of the pharmaceutical RA activity with US RA team. Compliance to US and French regulations.
• Preparation of Company's first pharmaceutical drug products registration files.
• Transfer activities preparation (potential gaps assessment, recommendations to control and minimize).
• Support to ANSM and FDA inspections.
2004 - 2006RA team member for “Products” and “Facility” new projects. Miscellaneous pharmaceutical forms (solids, liquids).
• “In” manufacturing transfer of a range of INNs on behalf of a customer.
• Registration files preparation. Regulatory compliance support to customers.
• Coordination of major changes in the manufacturing Site Master File. Compliance with French site regulation.
• Transversal work with QA, manufacturing, engineering teams.
Mylan
- Regulatory Affairs Specialist
SAINT PRIEST Cedex2002 - 2004Management of a product range of 45 INNs. Miscellaneous pharmaceutical forms (solids, liquids).
• Coordination of the preparation of new marketing authorizations and variations applications. Registrations follow-up with authorities.
• Regulatory compliance.
• Merck training: Merck Project Management School.
Mylan
- Project Manager, Pharmaceutical Development
SAINT PRIEST Cedex2001 - 2002Management and coordination of the development of injectable drug products (EU market).
• Management of EU analytical and formulation development contract labs.
• Registration files preparation.
• Predevelopment work on high potential generic injectable drug products.
Martin J&J MSD
- Project Manager, Pharmaceutical Development
2000 - 2001Interim management and coordination of OTC products development (EU market).
Pharmacy Faculty - Formulation oriented Thesis (Dec. 1999): “Flash” disintegrating tablets: Experimental comparison of current disintegrating agents, highlight on new excipients and use in pharmaceutical formulations
